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Comparison of Reduced Cuff-pressure of the Laryngeal Tube Under General Anesthesia (LTS)

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ClinicalTrials.gov Identifier: NCT02300337
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Marc Kriege, Johannes Gutenberg University Mainz

Brief Summary:
Optimization the cuff pressure of the laryngeal tube (LT) in relation of the mechanical ventilation, and the reduction of potential leakage mucosal trauma. Comparison of the tightness of LT between the filling volume specified by the manufacturer (connectors are color coded syringe and blocker), 60cmH₂O, 50cmH₂O, 40cmH₂Ound 30cmH₂O. The measurement of the leakage occurs in ml / kg body weight.

Condition or disease Intervention/treatment Phase
Airway Morbidity Device: Reduce Cuff pressure Not Applicable

Detailed Description:

The ventilation of both cuffs of the laryngeal tube by using the color coding of syringe and connector is a simple, fast and easy way to stabilize the tube and secure seal against the surrounding tissue.

The user of this method has only knowledge of the volume (ml), with which the cuff is vented, but not over the cuff pressure (cmH₂O) itself.

Permanently high pressures can cause to a lesions to necrosis in the adjacent tissue, on the other hand, the material of the bulging cuff fits less well the anatomy of the patient, leading to leaks in the breathing circuit.

Studies of pediatric anesthesia show that on 40cmH₂O reduces the volume of the leak in the laryngeal mask airway by reducing the cuff pressure and the ventilation is improved in sequence.

In the proposed study, the volume of leakage at the fill volume specified by the manufacturer (color coding), 60cmH₂O, 50cmH₂O, 40cmH₂O and 30cmH₂O to be captured.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Tightness of the Laryngeal Tube Under Mechanical Ventilation Before and After Reduction of Cuff Pressure on 60cmH₂O, 50cmH₂O, 40cmH₂O or 30cmH₂O
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Reduce Cuff Pressure
Cuff Pressure difference between inspiration and expiration is measured.
Device: Reduce Cuff pressure
We reduce the Cuff Pressure from the LTS-D (Laryngeal Tube suction) from 60 to 50 to 40 to 30cmH2O and measure the Delta from Inspiration to Expiration Tidalvolume (Delta Vt). The Delta Vt shows the actual leakage.




Primary Outcome Measures :
  1. Comparison of Leakage between the different Cuff Pressure [ Time Frame: < 5 Minutes ]
    We want to measure the tightness of the reduced Cuff Pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 Years
  • No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia
  • Height> 150cm

Exclusion Criteria:

  • Age <18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification> 3
  • situations where the possibility of accumulated gastric contents
  • Indications for intubation with endotracheal tube
  • Height <150cm
  • Participation in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300337


Locations
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Germany
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, Germany, D55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Rüdiger Noppens, MD University JG, Mainz

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Kriege, Marc Kriege,MD, Rüdiger Noppens, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02300337     History of Changes
Other Study ID Numbers: JohannesGU
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

Keywords provided by Marc Kriege, Johannes Gutenberg University Mainz:
laryngeal tube
cuff pressure
leakage
laryngeal mask